Budesonide/formoterol 100/6, 200/6 Turbohaler® (Symbicort  SMART®) - asthma

SMC recommendation
Advice: following a full submission
budesonide/formoterol turbohaler (Symbicort® SMART®) is accepted for use within NHS Scotland, in adults, for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting beta2-agonist) is appropriate; Symbicort is taken as regular maintenance treatment and as needed in response to symptoms.
In patients using inhaled budesonide/formoterol as preventer therapy, use of the same inhaler for reliever therapy is associated with a longer time to first severe exacerbation than use of comparator reliever regimens. In addition, some patients may be able to reduce the dose of preventer therapy.
Click here for SMC link
Tayside recommendation
Formulary
Points for consideration:
  • The budesonide/formoterol combination dry powder inhaler, Symbicort Turbohaler®, has been  licensed in the UK for maintenance therapy in asthma since 2001.  The licence for the 100/6 and 200/6 strength inhalers has recently been extended to cover use as both maintenance and reliever therapy (known as the Symbicort SMART® regimen) in patients over 18 years.
  •  Whilst both salmeterol and formoterol are long-acting beta2-agonists (LABAs), formoterol has a faster onset of action than salmeterol and can be used to relieve bronchoconstriction.  (The fluticasone/salmeterol combination inhaler, Seretide®, is unsuitable for use as reliever therapy).
  • The Symbicort SMART® regimen has shown superiority, in terms of increased time to first severe exacerbation, compared to traditional fixed-dose inhaled corticosteroid (ICS)/LABA plus as needed short-acting beta2 agonist (SABA).  Studies indicate that asthma can be controlled with a lower ICS “load” using the Symbicort SMART® regimen.
  •  Concerns that the use of LABAs may be associated with increased risk of asthma related deaths in certain susceptible individuals has prompted the MHRA to conduct an ongoing assessment of the risks and benefits associated with LABAs.  Click here for CHM advice.
  • The Symbicort SMART® maintenance dose is 2 puffs daily (one puff twice daily or 2 puffs once daily).  For some patients, a maintenance dose of 2 puffs twice daily may be appropriate.  Patients should take one additional puff as needed in response to symptoms.  If symptoms persist after a few minutes, an additional puff should be taken.  Not more than 6 puffs should be taken on any single occasion.  The SPC advises that a daily dose of more than 8 puffs is not normally needed; however a total daily dose of up to 12 puffs can be used for a limited period.  Patients using more than 8 puffs daily are recommended to seek medical advice and should be reassessed.
  • Use of a single inhaler as both maintenance and reliever therapy has potential benefits for patients who show poor compliance with traditional asthma treatment regimens involving two or more different inhalers.
    Note:
  •  the Turbohaler®  requires an adequate inspiratory flow rate (at least 30 l/min) to activate the device.
  • use of a pressurised metered-dose-inhaler (pMDI) plus spacer is preferred in patients on high doses of inhaled corticosteroids (ie > 800mcgs budesonide per day) to minimize oropharyngeal deposition and reduce the risk of systemic and local adverse effects.
  • Local guidance on Managing chronic asthma is available in the Tayside Area Formulary (TAF).
  • Prescribe combination inhalers by brand name to avoid potential confusion.

Locally, the Symbicort SMART® regimen is restricted to patients with moderate-to-severe persistent asthma at SIGN/BTS step 3 or patients who are poorly controlled (above BDP 400mcg/day) at SIGN/BTS step 2, and may be considered as an alternative option to traditional fixed-dose ICS/LABA plus as needed SABA.